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The PI-CAI challenge aims to validate the diagnostic performance of artificial intelligence (AI) and radiologists at clinically significant prostate cancer (csPCa) detection/diagnosis in MRI, with respect to histopathology and follow-up (≥ 3 years) as reference. The study hypothesizes that state-of-the-art AI algorithms, trained using thousands of patient exams, are non-inferior to radiologists reading bpMRI. As secondary end-points, it investigates the optimal AI model for csPCa detection/diagnosis, and the effects of dynamic contrast-enhanced imaging and reader experience on diagnostic accuracy and inter-reader variability.
This is an observational study in which patient data from the past on men with prostate cancer are studied. Cancer is a condition in which the body cannot control the growth of cells and tumors may form. If tumors form in the prostate, male sex hormones (androgens) can sometimes help the cancer spread and grow. Cancer that spreads to other parts of the body is called metastasis. Androgens are mainly made in the testicles. There are treatments available for men with prostate cancer to lower the levels of these hormones in the body. These treatments are called androgen deprivation therapy (ADT). Some men with prostate cancer respond to ADT, but in some cases, prostate cancer may overcome the therapy and worsen despite low androgens levels. Second generation androgen receptor inhibitors (SGARIs) including darolutamide, apalutamide, and enzalutamide are available for the treatment of prostate cancer in addition to ADT. SGARIs work by blocking androgens from attaching to proteins in cancer cells in the prostate. Clinical studies have shown that men with prostate cancer benefit from these treatments. But besides benefits, unfavorable reactions related to these treatments also influence which treatment is chosen, if the treatment is taken as intended or if it is even stopped. Unfavorable reactions observed for darolutamide, apalutamide, and enzalutamide differ from each other. In clinical trials, severe unfavorable reactions occurred less often for darolutamide. But information on how unfavorable reactions of each treatment influence their intake in actual or "real-world" prostate cancer treatment is missing. The main aim of this observational study is to learn to what extent SGARI treatments are taken as prescribed and how often their intake is completely stopped. To find this out, researchers will collect available treatment data of adult men with prostate cancer from the United States who started SGARI treatments between August 2019 and March 2021. The data will be drawn from the IQVIA database. For each man, data from up to 1 year prior SGARI treatment until at least 3 months after treatment start (up to the 30 June 2021) will be collected. The researchers will look at the percentage of men who: - completely stopped to take their treatment or - took the treatment as prescribed. The results for each treatment (darolutamide, apalutamide, and enzalutamide) will then be compared to find possible differences. There will be no required visits with a study doctor or required tests in this study since only patient data from the past are studied.
Patients will receive a single dose of 68Ga-PSMA-11 and undergo a PET/CT or PET/MRI imaging study.
This is an observational study where prostate cancer related PROMs (EPIC-26) is collected using two different methods (by paper questionnaires and electronically) and patient experience and preference is asked.
This is a randomized, open-label and parallel phase I study to compare pharmacokinetics (PK), pharmacodynamics (PD) and safety of goserelin acetate sustained-release microspheres for injection (LY01005) and ZOLADEX® following multiple administration in patients with prostate cancer.
This study will assess the effectiveness of a natural nutraceutical in treating the known side effects of chemotherapeutic agents in cancer patients.
Obtain PSMA-PET imaging preoperatively and calculate performance for predicting extra-prostatic extension based on whole-mount pathology (gold standard). Quantify the frequency of proper treatment changes directed by PSMA-PET, focusing on appropriate preservation of surrounding structures important for genito-urinary function including: 1) Bladder neck, 2) Nerve bundles, 3) Urethral Sphincter (Figure 4). Directly compare PSMA-PET performance for predicting extra-prostatic extension to standard-of-care assessments. Assess quality of life changes from preoperative baseline.
Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
The objective of this study is to compare changes in neurocognitive function across a 12-month period between three groups: (1) men treated with androgen deprivation therapy (ADT) for prostate cancer (PCa); (2) men under active surveillance for PCa; and (3) men without a history of cancer.
Ga-68 PSMA-11 PET/CT is known as useful method for localizing recurred tumor lesions in prostate cancer patients with biochemical recurrence [elevated serum prostate specific antigen (PSA) after radical prostatectomy]. The recent digital PET/CT which is known to show better resolution and sensitivity than analogue PET/CT may have better performance for detecting early small recurred tumor lesions. This study is intended to compare the diagnostic performance (detection rate and positive predictive value) of Ga-68 PSMA-11 PET/CT using analogue PET/CT scanner and digital PET/CT scanner in same patients who had biochemical recurrence of prostate cancer.